CCHS Secure Health-hub Advancing Research Efforts (CCHS SHARE)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorAnn & Robert H Lurie Children's Hospital of Chicago
About this trial
The purpose of this study is to capture longitudinal natural history data in Congenital Central Hypoventilation Syndrome (CCHS). This will include capturing standardized clinical data from standard of care assessments at several CCHS referral centers. Funding source-FDA OOPD
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Any individual with a confirmed CCHS diagnosis treated clinically at any of the participating sites.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Patient Quality of Life
Patient reported outcome common data elements reflecting core aspects of CCHS will be captured using the Pediatric Quality of Life Inventory (PedsQL) and the 36-item Short Form Health Survey (SF-36)
Time frame
Up to every 14 months2
Caregiver Burden
Caregiver burden will be assessed using the Zarit Burden Interview
Time frame
Up to every 14 months3
Patient and Caregiver Sleep
Patient and caregiver sleep will be assessed using PROMIS Sleep Disturbance and Sleep-Related Impairment short forms
Time frame
Up to every 14 months4
Autonomic Symptom Profile
Validated measures of autonomic function will be captured including data elements from COMPASS-31 and a patient-reported clinical and disease-specific outcomes symptomatology questionnaire relating to CCHS.
Time frame
Up to every 14 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ann & Robert H Lurie Children's Hospital of Chicago
Lead sponsor
Groupe Hospitalier Pitie-Salpetriere
Collaborator
Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborator
Hopital Universitaire Robert-Debre
Collaborator
Source ClinicalTrials.gov